JP2012254319A - Vascular access device antimicrobial materials and solutions - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device to reduce the rate of occurrence of blood stream infection in a patient to whom the medical device is attached.SOLUTION: The medical device includes a body and a septum 22 placed within the body and having a slit and a surface additionally, and layers 40, 42, and 44 including an antimicrobial agent on or the surface. Furthermore, a method for repressing a pathogen in a vascular access device 10 includes providing the vascular access device provided with the body and the septum having the surface and the slit for providing the access through the vascular access device, providing the layer having the antimicrobial agent, and disposing the layer on the surface.

Description

  The present disclosure relates to infusion therapy with a tube access device.

  Infusion therapy is one of the most common health care measures. Hospitalized, home care, and other patients receive fluids, medications, and blood products via a vascular access device inserted into the vascular system. Infusion therapy treats infections, provides anesthesia and analgesia, provides nutrition, treats cancer growth, maintains blood pressure and heart rate rhythm, and many other clinically important Or used for use.

  Infusion therapy is facilitated by a tube access device. The vascular access device can access the patient's peripheral or major vasculature. Tube access devices can be inherent for short periods (days), moderate periods (weeks), or long periods (months to years). The vascular access device can be used for continuous infusion therapy or intermittent therapy.

  A common tube access device is a plastic catheter that is placed into a patient's blood vessel. The length of the catheter can vary from 2-3 centimeters for peripheral access to multiple centimeters for central access. The catheter can be inserted through the skin or surgically buried under the patient's skin. The catheter or other tube access device attached to it may have a single lumen or multiple holes to infuse many fluids simultaneously.

  The proximal end of the tube access device typically includes a luer adapter to which other medical devices can be attached. For example, the dosing set can be attached at one end to a tube access device and at the other end to an infusion (IV) bag. The administration set is a fluid conduit for continuous infusion of fluids and drugs. In general, an IV access device is a tube access device that can be attached to another tube access device, closing or sealing the tube access device, and allowing intermittent infusion or injection of fluids and drugs . The IV access device may include a housing and a septum for closing the system. The septum can be opened with a pointed cannula or male luer of the medical device.

  Complications related to infusion therapy can result in significant morbidity and mortality. One important complication is catheter-related bloodstream infection (CRBSI). Estimates for 250,000-400,000 cases of BSI-related central venous catheters (CVCs) in US hospitals exist once a year. The contributing mortality rate is estimated 12% to 25% for each infection and is the cost of the healthcare system from $ 25,000 to $ 56,000 per symptom appearance.

  Tubular access device infections leading to CRBSI enter the fluid flow path through either end of the fluid flow path after catheter insertion, which has not regularly cleaned the device, has not been sterilized, or after catheter insertion Can be caused by pathogens. Studies have shown that the risk of CRBSI increases with catheter retention time. When the vascular access device is contaminated, the pathogen attaches to the vascular access device, forms a colony, and forms a biofilm. Biofilms are resistant to most biocides and provide a source of pathogens that enter the patient's bloodstream, resulting in BSI. Therefore, what is needed is a system, device, and method for reducing the risk and occurrence of CRBSI.

  The present invention has been created for problems and needs in the art that have not yet been fully solved by currently available tube access systems, devices, and methods. Accordingly, these systems, devices and methods have been developed to reduce the risk and occurrence of CRBSI.

  The medical device can be a tube access device that includes a surface and a layer of the device that can include an antimicrobial agent. The layers of the device can be combined with or combined with the material of the body of the tube access device. The body of the tube access device can include a septum housed within the body. The septum may include a slit having a surface.

  The layer may comprise a solution comprising a mixture of antimicrobial agent and lubricating oil that covers the surface of the slit. The second layer in contact with the device layer may include a lubricating oil having a low coefficient of friction. The layer may include a polymer coating having a low coefficient of friction that covers the surface of the slit. The second layer in contact with the device layer may include a polymer coating having a low coefficient of friction. The layer can include a radioisotope.

  The surface can be the top surface of a septum that includes a polymer coating having a low coefficient of friction covering the surface. The second layer in contact with the device layer may include a polymer coating having a low coefficient of friction. The layer can include fluorinated silicone. The second layer can be in contact with the layer of the device and can be dissolved in the first cleaning compound, and the second cleaning compound can be resistant, whereas the layer is dissolved in the second cleaning compound. And is resistant to the first cleaning compound.

  A method for depositing an antimicrobial agent on or in a surface of a medical device includes providing a heat resistant tube having a proximal end and a distal end and including a plurality of holes extending through the surface, and a tube access device. Preparing a tube access device containing a septum with slits forming two opposing inner surfaces along its length, and pipes the slits so that the distal holes face the two opposing inner surfaces of the slit Inserting the distal end of the substrate, placing the coating solution with the antimicrobial agent into the proximal end, and delivering the solution to the two opposing inner surfaces through the holes in the distal end.

  The heat resistant tube can include metals, polymers, polytetrafluoroethylene, and / or materials having a low coefficient of friction. The solution may be a solvent held on two opposing inner surfaces at about 150 ° C. for about 15 minutes.

  The means for accessing the patient's vasculature can comprise means for inhibiting pathogens that may be present in the means for accessing the patient's vasculature. The means for controlling pathogens can include slit partition walls containing antibacterial agents. The antibacterial agent can be coated on the surface of the septum and / or can be combined, mixed, or integrated with the septum material.

  These and other features and advantages of the present invention will be incorporated into particular embodiments of the present invention and will become more fully apparent from the following description and appended claims, or set forth below. As can be understood by the practice of the present invention. The present invention does not require that all advantageous features and all described advantages be incorporated herein into all embodiments of the invention.

1 is a perspective view of an extravascular system connected to a patient's vasculature. FIG. It is sectional drawing of the silicone partition containing a radioisotope. FIG. 5 is a cross-sectional view of a septum including antimicrobial coatings that are alternately stacked. FIG. 4 is an enlarged cross-sectional view of a part of the alternately overlapping coatings and partitions of FIG. FIG. 5 is an enlarged cross-sectional view of a portion of the alternately overlapping coating of FIG. FIG. 6 is a cross-sectional view of a tube access device having a plurality of antimicrobial coatings on the top surface of a septum. FIG. 6 is a cross-sectional view of a tube access device having a plurality of antimicrobial coatings on the inner surface of a septum. It is a side view of a part of a pipe having a plurality of holes in the closed end of the pipe. 2 is a flow diagram illustrating steps for coating the surface of a tube access device with an antimicrobial coating.

  In order that the manner in which the above and other features and advantages of the invention may be obtained will be readily understood, a more detailed description of the invention briefly described above is provided by way of example embodiments illustrated in the accompanying drawings. Will be provided by reference. The drawings represent only representative embodiments of the invention and therefore should not be construed as limiting the scope of the invention.

  The presently preferred embodiments of the invention will be best understood with reference to the drawings. Similar reference numbers indicate identical or functionally similar elements. It will be readily appreciated that the components of the present invention may be arranged and designed in a wide variety of different configurations, as generally described and illustrated herein. Accordingly, the following more detailed description is presented in the drawings, but is not intended to limit the scope of the claimed invention and is merely representative of the presently preferred embodiments of the invention.

  Now referring to FIG. 1, a tubular access device 10 (also referred to as an extravascular device, a venous access device, an access port, and / or any device attached to or working with an extravascular system) It is used to introduce material through the catheter 12 across the skin 14 of the patient 18 and into the blood vessel 16. The tube access device 10 includes a body 20 with a lumen and a septum 22 placed in the hole. Septum 22 has a slit 24 through which a separate extravascular device 26, such as a syringe, can introduce material into the tube access device 10.

  The device 10 also includes a layer (explained with reference to the figures below), an extravascular system 28 and / or a septum 22 that includes at least one antimicrobial agent on or in the surface of the device 10. . The layers can be integrated or integrated directly into the material of the tube access device 10, the septum 22 and / or the system 28. The layer of antibacterial agent suppresses at least one pathogen to reduce the incidence of bloodstream infections in patients with vascular access device 10 or any other device connected to extravascular system 28 attached To do.

  As explained throughout this specification, pathogens can cause disease if accepted into the patient's vasculature, otherwise adversely affect the patient, or adversely affect the patient. Including any pathogens, bacteria, parasites, microorganisms, biofilms, fungi, viruses, proteins that carry pathogens, protozoa, and / or other harmful microorganisms and / or agents and their products Including. The layer suppresses the pathogenic activity with respect to the pathogen by any one or combination of the following actions. Next action is to eliminate, remove, inhibit growth, attract to a position, drive away from a position, degenerate, fail, extinguish, prevent growth and proliferation Divergence, and / or any other similar process or activity.

  Pathogens can enter device 10 or system 28 in any of a number of ways. For example, pathogens may be present in device 10 or system 28 prior to initial use. Pathogens can also be removed from the outer surface of the device, from the outer surface of the separate device 26, and / or around when a component, such as the tip 30 of the separate device 26, is inserted into the device 10 through the slit 24 in the septum 22. It can be introduced into the device 10 from the environment. Pathogens can be introduced into fluids that are injected into the system from a separate device 26. Finally, pathogens can be introduced from the blood vessel 16 into the system 28 by entering through the end 32 of the catheter 12 during blood collection or during the period of blood reflux when the device 10 is in use. . Thus, the layer may be positioned at or on any surface of the inlet, junction, and / or flow path of the system 28 to suppress disease-causing activity as desired.

  Referring now to FIG. 2, the tube access device 10 includes a septum 22 housed within or against the surface of the body 20 of the tube access device 10. The septum 22 is an example of a layer on the surface of the body 20 of the tube access device 10. The partition wall 22 includes a radioisotope mixed in the material of the partition wall 22. The material of the partition wall 22 can be formed of silicone or a material having similar characteristics. A mixture of silicone with a radioisotope will provide a material with multiple unstable nuclei that emits alpha, beta, or gamma rays and decays until stability is achieved. During decay, the material emits radiation that is dangerous to the pathogen. Thus, any pathogen that is in close proximity to or in contact with the layer described with reference to FIG. 2 will be suppressed. The layer of FIG. 2 may include any of the materials or solutions described throughout this specification to control pathogens.

  Various antimicrobial lubricating oils or other lubricating oils can be mixed with the silicone of the septum 22 to provide an antimicrobial environment near the septum 22 as also described with reference to FIG. . Such an environment will control pathogens because oil or lubricating oil will ooze out of the material of the septum 22. For example, the fluorinated silicone can include an antimicrobial agent that is, for example, triclosan, chlorhexidine, dihydrochloride and / or chlorhexidine groups. The combination of fluorosilicone with triclosan can cause some recrystallization to form a clean solution. However, chlorhexidine, dihydrochloride and chlorhexidine groups mixed with fluorinated silicone appear to provide a stable release of lubricating oil from the silicone material during use of the septum 22.

  Each of these three antibacterial lubricants described immediately above is positioned on a Whitman No. 2 filter paper punch and sent to determine the zone, The pathogen was either suppressed or otherwise inhibited in the area directly surrounding two drops of each liquid. These results for various pathogens or bacteria are summarized in Table 1 below. This result suggests that the combination of silicone with the antimicrobial lubricant is likely to provide an environment in the tube access device 10 that can control pathogens.

  Silicone lubricants on the surface of the septum, or incorporated into the material of the septum, can prevent many pathogens, such as bacteria, from attaching to the surface of the device 10 Any of the antifouling materials can be included. Such antifouling material can be applied to any surface of device 10. Since the pathogen will not be able to attach to such a surface, the pathogen will not be able to form a harmful biofilm that can later cause illness to the patient.

  Referring now to FIG. 3, the tube access device 10 includes at least one layer formed by a septum 22 that has alternating coatings 34 of various materials on the surface of the septum 22. Each of the overlying coatings 34 can be dissolved in a variety of compounds to be flowed through the slits 24 in the septum 22 during use of the device 10. In addition, each of the alternating coatings 34 can include any of the antimicrobial materials and / or solutions described herein, including the antimicrobial agents listed in Table 2 below. . The agents described in Table 2 are used with the various embodiments of the present invention individually or in any combination with any other agent in Table 2 to provide a pathogenic environment or cocktail. be able to. Various agents can be applied to the cocktail to attract the pathogen so that the pathogen comes into contact with the mixture and then is harmed or extinguished upon receiving the remaining agent of the cocktail.

  Referring now to FIG. 4, an enlarged cross-sectional view of a portion of the alternating coating 34 of FIG. 3 is shown. The alternating coating 34 includes layers 36 present on the surface of the septum 22. Layer 36 includes an antibacterial agent, can be dissolved in cleaning compound A, and is resistant to compound B. The second layer 38 in contact with the layer 36 has resistance to the compound A and can be dissolved in the cleaning compound B. An additional layer 36 is present on the second layer 38 and an additional second layer 38 is present on the additional layer 36.

  Any compound can be used to flush the layer and additional layers 36, 38 from the surface of the septum 22, or otherwise dissolve. For example, brine (eg, Compound A) is often poured through the slits 24 in the septum 22 to clean the device 10. Then, after the device 10 has been cleaned, a drug (eg, Compound B) can be poured through the slit 24 in the septum 22 to treat the patient.

  Referring now to FIG. 5, the alternating coating 34 of FIG. 4 is shown and will be described in connection with an example of a method for melting the alternating coating 34. In use, the various layers of the alternating coating 34 will be removed as a result of flowing various compounds through the slits 24 in the septum 22. For example, the operator may pour or flush drug B over the additional second layer 38, identified as layer 1 in FIG. Since it is in contact with the second layer 38, it can be dissolved. However, because the adjacent additional layer 36, identified as layer 2 in FIG. 5, is resistant to the cleaning compound B or drug, that additional layer 36 will not dissolve. Layer 1 may or may not contain an antibacterial agent. However, layer 2 will preferably contain an antimicrobial agent that is released when device 10 is cleaned, causing salt water to flow into the device and dissolve in layer 2. Since layer 2 can be dissolved in salt water, layer 2 will dissolve. However, since the second layer 38, also identified as layer 3 in FIG. 5, cannot be dissolved in salt water, layer 3 will remain unaffected by the salt water until the operator has washed the device 10 with salt water. Since layer 2 includes an antimicrobial agent, the antimicrobial agent will mix with salt water during device cleaning and will inhibit any pathogens that come into contact with the antimicrobial agent in device 10 during cleaning.

  The operator can repeatedly use the device 10 by pouring a drug that can dissolve the layer 3. The operator can then pour salt water that is directly adjacent to the septum 22 and that can dissolve the layer 36 identified as layer 4 in FIG. The method described above with reference to FIG. 5, or any variation thereof, may change two or more resistant and / or resistant to various cleaning compounds as required by the operator. It can be used with the same number of alternating coatings of layers.

  The alternating coating 34 of the present invention can be adapted to various embodiments, as described above. The following embodiments reveal various alternatives to the embodiments described with reference to FIGS. 3-5 above.

  Referring now to FIG. 6, the tube access device 10 includes various antimicrobial coatings on the top surface of the septum 22 of the tube access device 10. The antimicrobial coating includes a top layer 40, an intermediate layer 42, and a bottom layer 44. Any number of layers may be placed on the top surface of the septum 22. The partition wall 22 is formed of an elastomeric material such as silicone.

  The antimicrobial coating can be formed from a variety of materials and solutions and can include any of the antimicrobial agents mentioned throughout this specification. For example, the antibacterial coating layer is a polymer coating having a low coefficient of friction, preferably a low coefficient silicone coating with or without dissolving power. The coating may also be formed from a blend of a low modulus silicone coating with more than 5 percent antimicrobial agent by weight. The coating should be 0.2 micrometers or more thick, preferably 0.5 micrometers or thicker, most preferably between 0.5 and 5.0 micrometers thick. Would be.

  One of many different coating configurations is shown in FIG. 6, and many different coating configurations can be used. For example, the antimicrobial coating may comprise a single layer or multiple layers consisting of a blend of a low modulus silicone coating with an antimicrobial agent that is greater than 5 percent by weight. As another example, the bottom layer 44 may be a low coefficient of friction polymer coating and the top layer 40 may be a blend with a low coefficient silicone antimicrobial agent. As yet another example, the bottom layer 44 can be a blend of a low coefficient silicone coating with an antimicrobial agent and the top layer 40 can be a low coefficient polymer coating. As yet another example, the top layer 40 and the bottom layer 44 are formed of a low coefficient polymeric coating and the intermediate layer 42 is formed of a low coefficient silicone coating with an antimicrobial agent.

  Any coating or antimicrobial layer described herein can be adapted to the septum 22 using a variety of methods. For example, the coating can be spray painted, brushed, rolled, or applied by any conventional coating method. After the coating is applied to the septum 22 or any other layer, the coating may be held at about 150 ° C. for 15 minutes. Any number of additional coatings or antimicrobial layers may then be adapted to the cured coating.

  Referring now to FIG. 7, the tube access device 10 includes a plurality of antimicrobial coatings or layers positioned on the surface of the slit 24 of the septum 22. The antibacterial layer includes an inner layer 46, an intermediate layer 48, and an outer layer 50 located on the surface of the septum 22. The partition wall 22 is preferably formed of an elastomer such as silicone.

  The coatings 46, 48, 50 can be formed from a variety of materials and solutions. For example, any of the coatings can be made of a low coefficient polymer coating, preferably a low coefficient silicone coating with or without solvent. Any of the coatings may alternatively or additionally be a blend of a low coefficient silicone coating with more than 5 percent by weight of one or more antimicrobial agents. The various antimicrobial layers can include single or multiple layers that are blends of low coefficient silicone coatings with antimicrobial agents. The antimicrobial layer can also include an inner layer 46 that is a low coefficient polymer coating and an outer layer 50 that is a blend of a low coefficient silicone coating with an antimicrobial agent. The antimicrobial layer can also include an inner layer 46 that is a blend with a low coefficient silicone antimicrobial agent and an outer layer 50 that is a low coefficient polymer coating. The antimicrobial layer can also include an inner layer 46 and an outer layer 50 that are low coefficient polymer coatings, and an intermediate layer 48 that is a blend of low coefficient silicone coatings with antimicrobial agents.

  The various antimicrobial coatings or layers should be 0.2 micrometers or thicker, preferably 0.5 micrometers thick, more preferably 0.5 to 5.0 micrometers. The thickness between the meters. Each of the coatings may be held at about 150 ° C. for 15 minutes. Each of the coatings can then include any number or combination of single or multiple antimicrobial agents, including the antimicrobial agents described throughout this specification.

  Referring now to FIG. 8, a tube 52 having a plurality of holes 54 at the end of the tube 52 can be used to apply an antimicrobial coating to the inner surface of the slit 24 of the device 10 of FIG. The tube 52 is preferably a heat-resistant tube that has been perforated or otherwise formed with a hole 54 at the closed end of the tube. The position of the hole 54 should coincide with the inner surface of the slit 24 of the partition wall 22. The tube 52 can then be inserted into the slit 24 and the fluid antimicrobial coating can be injected into the tube 52 and sent through the hole 54 to conform to the surface of the slit 24.

  Now referring to FIG. 9, a method of applying at least one antimicrobial coating to the inner surface of the slit 24 is illustrated. The heat resistant tube 52 is drilled in step 56 with a hole 54 at the end of the closed tube. The tube 52 is then inserted into the slit 24 of the septum 22 at step 58. The refractory tube can be made of metal, polymer, or similar materials, and is preferably manufactured from polytetrafluoroethylene and / or other non-silicone low modulus materials. The tube 52 is then aligned with the slit 24 at step 60 such that the hole 54 of the tube 52 is in contact with the surface of the slit 24. The coating solution (with or without dissolving power) is introduced from the open top end of the tube 52 through the hole 54 of the tube 52 to the inner surface of the slit 24 in step 62. The coating solution is then held at 150 ° C. for 15 minutes at step 64. After holding the coating solution, the tube 52 is withdrawn from the slit 24 at step 66. The above method can be repeated or modified as necessary to apply various and multiple antimicrobial coatings to the slits 24 of the device 10.

  The embodiment described with reference to FIGS. 2-9 may be modified as follows to provide an antimicrobial lubricating oil coating on the surface of the septum 22. In this embodiment, the coating is a low modulus lubricating oil, which can be a silicone oil such as polydimethylsiloxane or polyphenylsiloxane, or a fluorinated silicone oil copolymer having a fluorine content of 5 percent to 100 percent. is there. The viscosity of the lubricating oil should be 300 cps or higher, preferably 900 cps or higher. The lubricating oil coating is a blend of lubricating oil and at least one antimicrobial agent. The lubricating oil coating should be no less than 0.10 milligrams per 0.54 square centimeters (0.084 square inches), and preferably no less than 0.40 milligrams per 0.54 square centimeters (0.084 square inches); Most preferably at least 0.60 milligrams per 0.54 square centimeters (0.084 square inches).

  A lubricating oil coating may be applied to one or more layers of the present invention, as described above. For example, the lubricating oil coating can be a single layer or multiple layers that are a blend of lubricating oil with at least one antimicrobial agent. The layer may also be arranged to include at least one inner layer 46 that is a low modulus lubricating oil and at least one outer layer 50 that is a blend of lubricating oil and at least one antimicrobial agent. On the other hand, the layer may be arranged to include at least one inner layer 46 that is a blend of lubricating oil and at least one antimicrobial agent, and at least one outer layer 50 that is a low coefficient lubricating oil. As another option, the layers include at least one inner layer 46 and outer layer 50 that are low coefficient lubricating oils and at least one intermediate layer 48 that is a blend of lubricating oil and at least one antimicrobial agent. As such, it may be arranged.

  The method of applying the antimicrobial coating described immediately above may be similar to the method of FIG. However, after the lubricating oil coating solution is introduced through the tube at step 62, the tube 52 is rotated inside the slit 24 to ensure a uniform distribution of the coating in the slit 24. In this way, the two opposing surfaces of the slit 24 are covered with an antimicrobial lubricating oil or other antimicrobial coating solution, consistent with the embodiments described herein.

  The invention may be embodied in other specific forms without departing from its structure, method, or other essential characteristics, as generally described herein and claimed below. The described embodiments are not limiting and should be taken into account in all respects only as an illustration. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the spirit and equivalent scope of the claims are to be embraced within their scope.

Claims (25)

A main body and a partition housed in the main body, including a slit and further having a surface, and a partition wall;
A medical device comprising a layer containing an antimicrobial agent disposed on the surface.   The medical device according to claim 1, wherein the layer includes a solution containing a mixture of the antibacterial agent and lubricating oil, and the solution covers the surface of the slit.   The medical device of claim 1, further comprising a second layer in contact with the layer of the device, the second layer comprising a lubricating oil having a low coefficient of friction.   The medical device of claim 1, wherein the surface is present in the slit and the layer comprises a polymer coating having a low coefficient of friction, the coating covering the surface of the slit.   The medical device of claim 1, further comprising a second layer in contact with the layer of the device, the second layer comprising a polymer coating having a low coefficient of friction.   The medical device of claim 1, wherein the surface is a top surface of the septum and the layer includes a polymer coating having a low coefficient of friction, the coating covering the surface.   The medical device of claim 6, further comprising a second layer in contact with the layer of the device, the second layer comprising a polymer coating having a low coefficient of friction.   The medical device according to claim 1, wherein the layer comprises fluorinated silicone. A second layer in contact with the layer of the device;
The second layer can be dissolved in the first cleaning compound,
The second layer is resistant to the second cleaning compound;
The layer of the device can be dissolved in a second cleaning compound; and
The medical device of claim 1, wherein the layer of the device is resistant to the first cleaning compound.   The medical device according to claim 1, wherein the layer contains a radioisotope. A method for controlling pathogens in a tube access device comprising:
Providing a tube access device comprising a body and a septum having a surface and a slit for providing access through the tube access device;
Providing a layer having an antibacterial agent; and
Disposing the layer on the surface.   The method of claim 11, wherein the layer comprises a solution comprising a mixture of the antimicrobial agent and lubricating oil, and the solution covers the surface of the slit.   The method of claim 11, further comprising a second layer in contact with the layer of the device, the second layer comprising a lubricating oil having a low coefficient of friction.   The method of claim 11, wherein the surface is present in the slit, and the layer comprises a polymer coating having a low coefficient of friction, the coating covering the surface of the slit.   The method of claim 11, further comprising a second layer in contact with the layer of the device, the second layer comprising a polymer coating having a low coefficient of friction.   The method of claim 11, wherein the surface is a top surface of the septum and the layer comprises a polymer coating having a low coefficient of friction, the coating covering the surface.   The method of claim 16, further comprising a second layer in contact with the layer of the device, the second layer comprising a polymer coating having a low coefficient of friction.   The method of claim 11, wherein the layer comprises fluorinated silicone. A second layer in contact with the layer of the device;
The second layer can be dissolved in the first cleaning compound,
The second layer is resistant to the second cleaning compound;
The layer of the device can be dissolved in a second cleaning compound; and
The method of claim 11, wherein the layer of the device is resistant to a first cleaning compound.   The medical device of claim 11, wherein the layer forms a septum housed within the tube access device, and the layer includes a radioisotope. A means of accessing the patient's vasculature, and
A means for controlling pathogens,
The pathogen is present in the means for accessing the vasculature of a patient; and
The medical device, wherein the means for suppressing the pathogen includes a slit partition wall containing an antibacterial agent.   The medical device according to claim 21, wherein the antibacterial agent is coated on the surface of the partition wall.   The medical device according to claim 21, wherein the antibacterial agent is mixed with a material of the partition wall. A main body and a partition housed in the main body, including a slit and further having a surface, and a partition wall;
A first layer comprising an antimicrobial agent disposed on the surface;
A second layer in contact with the first layer,
The second layer can be dissolved in the first cleaning compound,
The second layer is resistant to the second cleaning compound;
The first layer can be dissolved in the second cleaning compound; and
The first layer is resistant to the first cleaning compound;
Medical device. A method for controlling pathogens in a tube access device comprising:
Providing a tube access device comprising a body and a septum having a surface and a slit for providing access through the tube access device;
Disposing on the surface a first layer having an antibacterial agent, which is resistant to the first cleaning compound and is soluble in the second cleaning compound; and
Placing a second layer in contact with the first layer, wherein the second cleaning compound is resistant and soluble in the first cleaning compound.

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